Age-Related Memory DisordersPhase 2NCT00109564
A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
A Phase 2 study testing ispronicline (nicotinic acetylcholine receptor agonist) in people with Age-Related Memory Disorders, run by Targacept Inc. at 15 sites in United States.
Trial summary
The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment (AAMI). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Memory Disorders
- What is being tested?
- ispronicline (nicotinic acetylcholine receptor agonist)
- How many people
- 174 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2005to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 50-80 years.
- Lives with a significant other.
- Has subjective memory complaints. Verbal verification of this subjective memory complaint will be obtained from the significant other.
- Has no severe, uncontrolled medical condition.
- If receiving treatment for a medical condition, that treatment has been stable for at least 2 months before entering the trial and to remain stable throughout the trial.
Who cannot join
- Aged less than 50 years or greater than 80 years.
- Lives alone.
- Has any medical condition not adequately controlled, or likely to interfere with performance of the study procedures.
- Medication for a medical condition has been changed in the last 2 months or during the trial.
- Administration of acetylcholinesterase inhibitors and gingko biloba within 2 months prior to entering the study.
- Has evidence of depression or anxiety
- Meets DSM-IV criteria for Alzheimer's or vascular dementia.
- Has participated in an investigational drug trial in the previous 30 days.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Northlake Medical Research Center
Decatur, Georgia, 30033
Radiant Research
Denver, Colorado, 80212
Hartford Research
Florence, Kentucky, 41042
Neuropsychiatric Research Center of SW Florida
Fort Meyers, Florida, 33912
Kulynych Research Center
Greensboro, North Carolina, 27408
Pivotal Research Center
Mesa, Arizona, 85210
Berman Center
Minneapolis, Minnesota, 55404
Pivotal Research Center
Peoria, Arizona, 85381
Radiant Research Philadelphia
Philadelphia, Pennsylvania, 19115
Meridien Research
Saint Petersberg, Florida, 33709
Radiant Research
Salt Lake City, Utah, 84107
Radiant Research
San Antonio, Texas, 78229
Radiant Research
St Louis, Missouri, 63141
Meridien Research
Tampa, Florida, 33609
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)
The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss and poor concentration associated with aging.
- Conditions
- Age-Related Memory Disorders
- Being tested
- ispronicline (nicotinic acetylcholine receptor agonist)
- Keywords
- AAMI, Memory Impairment, Decline in Cognitive Function, Age Associated Memory Impairment
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ispronicline (nicotinic acetylcholine receptor agonist)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
To assess effect, on cognition, of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2005 (estimated)
- Study startJan 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Memory DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 174 participants
Sponsor and investigators
- Lead sponsor
- Targacept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109564
- Sponsor's protocol ID
- TC-1734-112-CRD-004
- Status last verified
- Jul 2008
- First submitted
- 28 Apr 2005
- Last updated
- 18 Jul 2008
- Results posted
- No
Publications
Dunbar GC, Kuchibhatla RV, Lee G; TC-1734 (AZD3480) AAMI Clinical Study Group (USA). A randomized double-blind study comparing 25 and 50 mg TC-1734 (AZD3480) with placebo, in older subjects with age-associated memory impairment. J Psychopharmacol. 2011 Aug;25(8):1020-9. doi: 10.1177/0269881110367727. Epub 2010 Jun 11.
PubMed 20542923
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)
- ClinicalTrials.gov ID
- NCT00109564
- Acronym / sponsor ID
- TC-1734-112-CRD-004
- Conditions
- Age-Related Memory Disorders
- Keywords
- AAMI, Memory Impairment, Decline in Cognitive Function, Age Associated Memory Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants
- Lead sponsor
- Targacept Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Oct 2005
- First posted
- 29 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss and poor concentration associated with aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 50-80 years.
- Lives with a significant other.
- Has subjective memory complaints. Verbal verification of this subjective memory complaint will be obtained from the significant other.
- Has no severe, uncontrolled medical condition.
- If receiving treatment for a medical condition, that treatment has been stable for at least 2 months before entering the trial and to remain stable throughout the trial.
Key exclusion criteria (8 listed)
- Aged less than 50 years or greater than 80 years.
- Lives alone.
- Has any medical condition not adequately controlled, or likely to interfere with performance of the study procedures.
- Medication for a medical condition has been changed in the last 2 months or during the trial.
- Administration of acetylcholinesterase inhibitors and gingko biloba within 2 months prior to entering the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ispronicline (nicotinic acetylcholine receptor agonist) | Drug | – |
Primary outcome
To assess safety and tolerability of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
To assess effect, on cognition, of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2008.
- Derived from this study: PubMed 20542923Dunbar GC, Kuchibhatla RV, Lee G; TC-1734 (AZD3480) AAMI Clinical Study Group (USA). A randomized double-blind study comparing 25 and 50 mg TC-1734 (AZD3480) with placebo, in older subjects with age-associated memory impairment. J Psychopharmacol. 2011 Aug;25(8):1020-9. doi: 10.1177/0269881110367727. Epub 2010 Jun 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ispronicline (nicotinic acetylcholine receptor agonist) in people with Age-Related Memory Disorders, run by Targacept Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess safety and tolerability of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00109564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2008; AzTrials last refreshed its copy on 7 Nov 2026.